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CompletedNCT00279825Updated Oct 29, 2019

Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

A Phase 2 interventional study of IPX054 200 mg and IPX054 250 mg in Idiopathic Parkinson's Disease, sponsored by Impax Laboratories, LLC. Completed at 2 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Impax Laboratories, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

Read the detailed description

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

  • levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
  • carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
02

Conditions studied

  • Idiopathic Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 16 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Impax Laboratories, LLC is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with idiopathic Parkinson's disease.
  • Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
  • Must experience "wearing OFF" between doses of medication.

Exclusion criteria

Exclusion Criteria:

  • Diagnosed with atypical parkinsonism.
  • Allergic or non-responsive to previous carbidopa-levodopa therapy.
  • Active or history of narrow-angle or wide-angle glaucoma.
  • History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures.
  • Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
  • Treatment with any dopaminergic blocking agent within the previous 3 months.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Other
    Sequence 1

    Subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR.

    Drug: IPX054 200 mg · Drug: IPX054 250 mg · Drug: CD-LD IR · Drug: CD-LD CR · Drug: IPX054 200 mg Placebo · Drug: IPX054 250 mg Placebo · Drug: CD-LD IR Placebo · Drug: CD-LD CR Placebo

  • Other
    Sequence 2

    Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo.

    Drug: IPX054 200 mg · Drug: IPX054 250 mg · Drug: CD-LD IR · Drug: CD-LD CR · Drug: IPX054 200 mg Placebo · Drug: IPX054 250 mg Placebo · Drug: CD-LD IR Placebo · Drug: CD-LD CR Placebo

  • Other
    Sequence 3

    Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.

    Drug: IPX054 200 mg · Drug: IPX054 250 mg · Drug: CD-LD IR · Drug: CD-LD CR · Drug: IPX054 200 mg Placebo · Drug: IPX054 250 mg Placebo · Drug: CD-LD IR Placebo · Drug: CD-LD CR Placebo

  • Other
    Sequence 4

    Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.

    Drug: IPX054 200 mg · Drug: IPX054 250 mg · Drug: CD-LD IR · Drug: CD-LD CR · Drug: IPX054 200 mg Placebo · Drug: IPX054 250 mg Placebo · Drug: CD-LD IR Placebo · Drug: CD-LD CR Placebo

Interventions

  • DrugIPX054 200 mg

    IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa

  • DrugIPX054 250 mg

    IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa

  • DrugCD-LD IR

    Active comparator containing 25 mg carbidopa and 100 mg levodopa

    Also known as: Carbidopa-levodopa immediate-release tablets

  • DrugCD-LD CR

    Active comparator containing 50 mg carbidopa and 200 mg levodopa

    Also known as: Carbidopa-levodopa controlled-release tablets

  • DrugIPX054 200 mg Placebo

    Placebo to match IPX054 200 mg

  • DrugIPX054 250 mg Placebo

    Placebo to match IPX054 250 mg

  • DrugCD-LD IR Placebo

    Placebo to match CD-LD IR

  • DrugCD-LD CR Placebo

    Placebo to match CD-LD CR

06

What researchers measure

Primary outcomes

  1. Alternate tapping of keys

    Time frame: single dose

Secondary outcomes

  1. Timed walking

    Time frame: single dose

  2. Tremor score

    Time frame: single dose

  3. Dyskinesia rating scale

    Time frame: single dose

07

Study locations

2 sites
  • Quest Research Institute
    Bingham Farms, Michigan 48025, United States
  • Oregon Health Sciences University - Parkinson's Center of Oregon
    Portland, Oregon 97239, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00279825
Lead sponsor
Impax Laboratories, LLC
Responsible party
Sponsor
First posted
Jan 20, 2006
Start date
Jan 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Oct 29, 2019

Study contacts

Impax Study Director
study director · Impax Laboratories, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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